FDA Inspection 864800 — Ascension Via Christi Hospitals Wichita Inc
The FDA completed an inspection of Ascension Via Christi Hospitals Wichita Inc on February 26, 2014 in Wichita, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 26, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Wichita, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 162 | 21 CFR 606.165(a) | Distribution and receipt - recalls |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |